GRAPPA-OMERACT initiative to standardise outcomes in psoriatic arthritis clinical trials and longitudinal observational studies

Tillett, William; Orbai, Ana‐Maria; Ogdie, Alexis; Leung, Ying Ying; Strand, Vibeke; Gladman, Dafna D.; Mease, Philip J.; Coates, Laura C.

doi:10.1136/annrheumdis-2017-212004

Cited by 17 publications

(10 citation statements)

References 7 publications

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“…The GRAPPA-OMERACT project is known by the acronym COMPACT (Core Outcome Measures for Psoriatic Arthritis Clinical Trials) (5). Figure 1 illustrates the COMPACT study design.…”

Section: Methodsmentioning

confidence: 99%

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

Orbai

Holland²,

Leung³

et al. 2018

J Rheumatol

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Objective.The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).Methods.PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).Results.PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted “yes” to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted “yes”; 82 participants were not PRP and 87% of them (71) voted “yes.”Conclusion.At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.

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“…The GRAPPA-OMERACT project is known by the acronym COMPACT (Core Outcome Measures for Psoriatic Arthritis Clinical Trials) (5). Figure 1 illustrates the COMPACT study design.…”

Section: Methodsmentioning

confidence: 99%

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

Orbai

Holland²,

Leung³

et al. 2018

J Rheumatol

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“…This was endorsed at the 2016 OMERACT meeting 1,2 . Since that time, many work streams have been initiated as part of the Core Outcome Measures for Psoriatic Clinical Trials (COMPACT) study 3,4 . The GRAPPA-OMERACT working group has been evaluating the measurement properties of multiple outcome measurement instruments to develop a PsA Core Outcome Measurement Set (COS) that would assist in standardizing what is measured in RCT and how they are measured (domains and instruments) 5,6 .…”

mentioning

confidence: 99%

Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report

Duarte‐García

Leung²,

Coates³

et al. 2019

J Rheumatol

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Objective.The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculoskeletal (MSK) disease activity domain. We report the Outcome Measures in Rheumatology (OMERACT) 2018 meeting’s approaches to seek endorsement of the 66/68 swollen and tender joint count (SJC66/TJC68) for inclusion in the PsA Core Outcome Measurement Set (COS).Methods.Using the OMERACT Filter 2.1 Instrument Selection Process, the SJC66/TJC68 was assessed for (1) domain match, (2) feasibility, (3) numerical sense (construct validity), and (4) discrimination (test retest reliability, longitudinal construct validity, sensitivity in clinical trials, and thresholds of meaning). A protocol was designed to assess the measurement properties of the SJC66/TJC68 joint count. The results were summarized in a Summary of Measurement Properties table developed by OMERACT. OMERACT members discussed and voted on whether the strength of the evidence supported that the SJC66/TJC68 had passed the OMERACT Filter as an outcome measurement instrument for the PsA COS.Results.OMERACT delegates endorsed the use of the SJC66/TJC68 for the measurement of the peripheral arthritis component of the MSK disease activity domain. Among patient research partners, 100% voted for a “green” endorsement, whereas among the group of other stakeholders, 88% voted for a “green” endorsement.Conclusion.The SJC66/TJC68 is the first fully endorsed outcome measurement instrument using the OMERACT Filter 2.1 and the first instrument fully endorsed within the PsA COS.

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“…The study is part of the OMERACT-Group for Research and Assessment of Psoriasis and PsoriaticArthritis (GRAPPA) Core Outcome Measures for Psoriatic Arthritis Clinical Trials project aiming to produce the evidence needed to standardize clinical trial outcomes in PsA. 14,15…”

Section: Methodsmentioning

confidence: 99%

Evidence for Psoriatic Arthritis Impact of Disease (PsAID12) as Core Instrument to Measure Health-Related Quality of Life in Psoriatic Arthritis: A Systematic Review of Psychometric Properties

Holland

Højgaard

Tillett

et al. 2019

Journal of Psoriasis and Psoriatic Arthritis

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Objective: To evaluate and update the evidence for the measurement properties of the Psoriatic Arthritis Impact of Disease (PsAID12) questionnaire to measure health-related quality of life (HRQoL) in psoriatic arthritis (PsA). Methods: The PsAID12 psychometric evidence was gathered in a systematic literature review in PsA (registration number: CRD42016032546). The study quality was appraised using the Consensus-based Standards for the selection of health Measurement Instruments–Outcome Measures in Rheumatology (COSMIN-OMERACT) good methods check-list. Content validity, test–retest reliability, construct validity, longitudinal construct validity, discrimination, and thresholds of meaning were appraised. Additional analyses for construct validity, responsiveness, and sensitivity to change were conducted in available observational data sets after prespecified hypotheses were formulated. Results: Eight publications (129-474 patients) were analyzed. The PsAID12 fulfilled OMERACT criteria for content validity (patients and physicians endorsed content match with PsA HRQoL domain), feasibility (endorsed by patients and physicians), and test–retest reliability (intraclass correlation coefficient: 0.91-0.95). A priori construct validity hypotheses were mostly met: Psoriatic Arthritis Impact of Disease had high correlation with generic ( r = 0.76-0.87) and PsA-specific HRQol measures (0.8), and with measures of physical function (0.66-0.72), work productivity (0.69-0.75), pain (0.83), and fatigue (0.84). Psoriatic Arthritis Impact of Disease had moderate-high correlation with measures of patient global (0.49-0.84) and dermatologic HRQoL (0.36-0.53). Correlations were higher with generic HRQoL measured by short form-36 physical component score (0.47-0.73) versus short form-36 mental component score (0.22-0.60). Three studies confirmed known group validity of PsAID12 according to PsA disease activity. Psoriatic Arthritis Impact of Disease discriminated between change groups in 2 longitudinal studies (standardized response mean: 0.74-0.91, 53 and 105 patients). The minimal clinically important improvement was 3 and 1.4 points. Conclusion: Psoriatic Arthritis Impact of Disease had evidence for good content and construct validity, reliability, and longitudinal construct validity and is ready to evaluate in clinical trials.

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GRAPPA-OMERACT initiative to standardise outcomes in psoriatic arthritis clinical trials and longitudinal observational studies

Cited by 17 publications

References 7 publications

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report

Evidence for Psoriatic Arthritis Impact of Disease (PsAID12) as Core Instrument to Measure Health-Related Quality of Life in Psoriatic Arthritis: A Systematic Review of Psychometric Properties

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